Device product
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Z-0301-2017
Product summary
- Firm
- Lumenis Limited
- Event
- Event 75384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69 units
- Official record key
device-enforcement:Z-0301-2017
Official wording
Reason: The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Code information: All serial numbers
Distribution pattern: Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
Derived failure modes
-
Unknown
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.